Duns Number:784259751
Device Description: TYSHAK-X 8X2X6X6X100X.035 PDC300
Catalog Number
618300
Brand Name
TYSHAK X™
Version/Model Number
618300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K022722
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
8b19170e-4b8a-4a71-b873-b2fd5464fd87
Public Version Date
March 25, 2020
Public Version Number
5
DI Record Publish Date
August 09, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1226 |
3 | A medical device with high risk that requires premarket approval | 361 |